Clinical Trials

Study Title

A Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Combination with Estradiol/Norethindrone Acetate in Subjects with Moderate to Severe Endometriosis-Associated Pain

Purpose

1) assess the safety and efficacy of elagolix 200 mg administered twice daily (BID) in combination with low dose Estradiol/Norethindrone acetate (E2/NETA) QD and elagolix 200 mg BID in combination with standard dose Estradiol/Norethindrone acetate (E2/NETA) QD compared to placebo at 6 months

2) to assess the effect of elagolix 200 mg BID in combination with low dose E2/NETA QD and elagolix 200 mg BID in combination with standard dose E2/NETA QD on bone mineral density (BMD) compared to placebo at 6 months and compared to elagolix 200 mg BID alone at 12 months in premenopausal women with moderate to severe endometriosis-associated pain.

Eligibility

Study Process